Fluarix Quadrivalent

Proper Name: Influenza Virus Vaccine (Quadrivalent, Types A & Types B)

FLUARIX QUADRIVALENT, Influenza Vaccine, for intramuscular injection, is a sterile, colorless, and slightly opalescent suspension. FLUARIX QUADRIVALENT is prepared from influenza viruses propagated in embryonated chicken eggs.

Advisory Board:

This submission was not discussed at a VRBPAC meeting because review of this submission did not identify concerns or issues which would have benefited from an advisory committee discussion.

Indications: FLUARIX QUADRIVALENT is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older.

Key Regulatory Milestones:

08/31/2005 – Fluarix was licensed in the U.S. under the accelerated approval regulations

10/02/2009 – Fluarix was granted ‘traditional approval’

10/19/2009 – Expansion of the age indication for children aged 3 years and older was approved (STN 125127/319).

12/14/2012 – Fluarix Quadrivalent (D-QIV) formulation was approved on (STN 125127/513)

01/18/2017 – Submitted the clinical study report to the IND

01/12/2018 – PDUFA Goal Date

07/02/2020 – FDA approval date

Package Insert